Sequential high-dose (sHD) chemotherapy yielded significantly higher single-induction complete remission (CR) rates with lower resistance risk, compared with standard-intensity idarubicin-cytarabine-etoposide (ICE) chemotherapy, according to results from a randomized study of 574 adults with acute myeloid leukemia (AML).
The study found that the sHD regimen had comparable mortality, improved 5-year overall survival (49% vs. 39%; p=0.045), and relapse-free survival (RFS) (48% vs. 36%; p=0.028) compared to ICE chemotherapy.
In patients aged 60 years and less with de novo AML, sHD chemotherapy also improved overall survival and RFS (hazard ratio, 0.70; 95% CI, 0.52-0.94; p=0.01).
The age range for patients enrolled in the study was 16-73 years, with a median of 52 years. Standard-risk patients received autograft or repetitive blood stem cell-supported high-dose courses. High-risk patients (and standard-risk patients not mobilizing stem cells) underwent allogeneic hematopoietic cell transplantation (HCT).
Of the 574 enrolled patients, 470 achieved total CR, and 193 (41%) of those patients underwent allogeneic HCT. The sHD-treated patients (n=91) in this cohort who underwent allogeneic HCT exhibited better outcomes than ICE-treated patients (n=102), with a 5-year survival of 69% vs. 55% (p=0.06) and RFS of 66% vs. 49% (p=0.03).
The researchers concluded that “sHD may be a valid alternative to the classic ‘3+7’ or ICE regimens for inducing early CR, particularly in high-risk patients, and to standard reinduction for patients unresponsive to a conventional first course.”